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NCT Number: NCT04385160

Myeloproliferative Neoplasms (MPN) and COVID-19

An increased risk of both venous and arterial thromboembolism was noted in reports from SARS-CoV-2-infected patients in China and has been confirmed in autopsy findings from patients who experienced sudden death. Myeloproliferative Neoplasms (MPNs), which encompass polycythemia vera, essential thrombocythemia and primary myelofibrosis, are thrombophilic disorders with a natural propensity to thrombosis that is fuelled by the intrinsic activation of inflammatory cytokines. It therefore follows that an underlying diagnosis of MPN may increase the risk of worse clinical outcomes and death during periods of active Covid-19 disease. This ambispective, observational study aims to elucidate the key factors which affect the clinical course of patients with MPN who develop Covid-19 disease.

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Key information

Conditions

Myeloproliferative Neoplasm Bone Marrow Diseases COVID Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Specialised Hospital for Active Treatment of Hematological Diseases, Sofia, Bulgaria

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About this study

This is an European multicenter observational study that will include around 550 MPN patients with a confirmed diagnosis of Covid-19 will be followed for at least one month. Detailed information on the clinical characteristics of these patients and their disease outcomes will be retrospectively and prospectively collected in a specific eCRF, including MPN characteristics, treatment and comorbidities pre-Covid-19, time of Covid-19 diagnosis, drugs/device used for the treatment of Covid-19, any change in MPN therapy, antithrombotic prophylaxis employed during the period of infection and - for hospitalised patients only - key blood and laboratory parameters. A particular focus will be on exploring final outcomes for patients in this study, most notably the incidence of fatal and non-fatal thrombotic events. Statistical analyses will also be performed looking for any independent factors that can significantly predict patient outcomes after Covid-19 diagnosis.

Ultimately, this project will provide important insights into disease severity and progression in patients with MPN and Covid-19 and uncover the key clinical factors which drive outcomes and mortality. Results may help clinicians better understand how patient characteristics and management decisions can impact on disease trajectory when MPN and Covid-19 collide.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Confirmed diagnosed of MPN according to WHO criteria
  • Diagnosis of COVID-19 based by the positivity of oropharyngeal swab performed between 15 February 2020 up to 15 February 2022
  • Signed informed consent

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. pulmonary embolism (PE)

    Time frame: 2 and a half months

    Incidence of cases of MPN patients with COVID-19 experiencing pulmonary embolism

Secondary outcomes

  1. fatal or non fatal thrombotic event

    Time frame: 2 and a half months

    Incidence of cases reporting at least one fatal or non fatal thrombotic event reported in therapy of MPN, , with particular focus to those occurred during hospitalization

  2. Continuous Positive Airway Pressure (CPAP)

    Time frame: 2 and a half months

    Incidence of cases reporting at least one COVID-19 worsening outcome as Continuous Positive Airway Pressure (CPAP)

  3. invasive ventilation

    Time frame: 2 and a half months

    Incidence of cases reporting at least one COVID-19 worsening outcome as invasive ventilation

  4. admission in Intensive Care Unit (ICU)

    Time frame: 2 and a half months

    Incidence of cases reporting at least one COVID-19 worsening outcome as Intensive Care Unit (ICU)

  5. death

    Time frame: 2 and a half months

    incidence of death

  6. treatments and interventions applied for MPN

    Time frame: 2 and a half months

    Type of treatments and interventions applied for MPN during COVID-19 and any change reported in therapy of MPN, particularly including:

    • Mortality rate by discontinuation of cytoreductive drugs
    • Mortality rate by time of exposure to cytoreductive drugs (before vs after Covid-19 pandemic)
    • Mortality rate by cytoreductive drugs use and/or discontinuation and MPN type (MF, PV, ET, pre-PMF)
    • Cause-specific mortality rate by cytoreductive drugs use and/or discontinuation

  7. treatments and interventions applied for COVID-19

    Time frame: 2 and a half months

    Type of treatments and interventions applied for COVID-19,

  8. thrombotic events association to patients characteristic and treatments

    Time frame: 2 and a half months

    Odds Ratios (ORs) of the outcome and 95% Confidence Intervals (CIs) associated with patients' characteristics and treatments

  9. Mortality rate occurring in the single MPN phenotypes in relation to cytoreductive treatment

    Time frame: 2 and a half months

    incidence of death in phenotype subgroups and by cytoreductive categories of drug

  10. MPN progression rate

    Time frame: 2 and a half months

    Incidence of evolution to leukemia, myelofirbrosis and/or second cancers MPN, evaluated by cytoreductive drugs and therapy administered for COVID-19 as terms of interaction

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

Registry information

Acronym: MPN-COVID

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 12, 2020
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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